CHMP Backs Ozempic Label Update for Kidney Benefits
Novo Nordisk announced that the EMA's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for an update of the Ozempic (once-weekly subcutaneous semaglutide) label to reflect data from the FLOW kidney outcomes trial.
The FLOW trial assessed the risk reduction from Ozempic therapy in chronic kidney disease-related events, including persistent ≥50% decline in estimated glomerular filtration rate (eGFR), onset of persistent eGFR <15 ml/min/1.73 m2, initiation of chronic kidney replacement therapy, kidney death or cardiovascular death in adults with type 2 diabetes and chronic kidney disease (CKD). In the FLOW trial, semaglutide 1.0 mg demonstrated a statistically significant and superior 24% risk reduction in kidney disease progression as well as cardiovascular and kidney death compared to placebo. In addition, the secondary endpoints in the trial showed that the risk of major cardiovascular events was reduced by 18%, and the risk of all-cause mortality was reduced by 20%.
Novo Nordisk has also filed for a label expansion in the US, and a decision is expected in the first half of 2025.
Approximately 40% of people with type 2 diabetes develop chronic kidney disease, and there is a need for treatments that can help to reduce kidney disease progression," said Martin Holst Lange, executive vice president for Development at Novo Nordisk. “With this positive opinion, Ozempic will become the first and only GLP-1 receptor agonist to show lowering of risk of kidney disease progression in adults with type 2 diabetes and chronic kidney disease."
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